FDA: Size of bio-batch [Regulatives / Guidelines]

posted by jag009  – NJ, 2013-12-10 21:03 (3652 d 10:10 ago) – Posting: # 12032
Views: 11,408

(edited by jag009 on 2013-12-11 16:21)

Hi Helmut,

❝ Do you know of a corresponding requirement by the FDA? In the Summary Table 11 sizes of the bio-batch and production batch have to be reported.

We always make > 100,000 tablets. See page 2 of FDA Guidance I know it's old...

Hope that helps...


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